Drug-drug InteractionPhase 1NCT03826602
A Drug-Drug Interaction Study in Healthy Volunteers of the Effects of Tucatinib on Metformin
A Phase 1 study testing Tucatinib, Metformin and Iohexol in people with Drug-drug Interaction, run by Seagen Inc. at 1 site in United States.
Trial summary
This study is being done to look at how tucatinib might affect the way another drug (metformin) works. It will look at healthy volunteers and how tucatinib affects how the body absorbs metformin. This will help us find out whether tucatinib is safe to give together with metformin. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Drug-drug Interaction
- What is being tested?
- Tucatinib, Metformin and Iohexol
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Feb 2019to 15 Mar 2019
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy status, as defined by the absence of evidence of any clinically significant findings
- Males must agree to use a barrier method of birth control and not donate sperm during study plus 30 days after last dose of study drug
- Weight of ≥60kg
- Body mass index between 18.0 and 32.0 kg/m² (inclusive)
- Ability to abstain from alcohol-, caffeine-, and xanthine-containing food and beverages from 48 hours prior to admission through study discharge
- All nonregular medication (including over-the-counter medication, health supplements, and herbal remedies) must be stopped at least 28 days prior to admission
Who cannot join
- Females who are of childbearing potential or lactating
- Males with female partners who are pregnant, lactating, or planning to become pregnant within 30 days of the study
- Use of any investigational drug or device within 30 days of study start
- Use of tobacco products within 21 days prior to admission
- Routine or chronic use of more than 3 grams of acetaminophen daily
- Strenuous activity, sunbathing, and contact sports within 72 hours prior to first admission and for the duration of the study
Show all 14Show fewer
- Blood transfusion within 90 days of study drug administration
- History of alcoholism or drug abuse within 2 years
- History of alcohol consumption exceeding 7 drinks/week for female participants or 14 drinks/week for male subjects
- History of donation of more than 450 mL of blood within 60 days prior to dosing, or planned donation before 30 days have elapsed since intake of study drug
- Plasma or platelet donation within 7 days of initial study drug administration
- Positive screening test for Hepatitis B, Hepatitis C, or HIV 1 or 2 (human immunodeficiency virus)
- Acute or chronic metabolic acidosis, including diabetic ketoacidosis
- Renal disease or dysfunction as suggested by serum creatinine levels or abnormal creatinine clearance
Trial locations and contacts
1 site in 1 country.
United States1 site
Pharmaceutical Research Associates
Salt Lake City, Utah, 84107
About this study
Official title: A Phase 1, Open-Label, Fixed-Sequence, Drug-Drug Interaction Study to Evaluate the Effects of Tucatinib of the Pharmacokinetics of Metformin in Healthy Male and Female Subjects
This study is being done to look at how tucatinib might affect the way another drug (metformin) works. It will look at healthy volunteers and how tucatinib affects how the body absorbs metformin. This will help us find out whether tucatinib is safe to give together with metformin. The study will also look at how tucatinib affects how the kidneys work.
Read the detailed description
This is a single center, fixed-sequence, drug-drug interaction study to assess the effects of multiple oral doses of tucatinib on the pharmacokinetics of a single oral dose of metformin in healthy subjects. The primary objective of the study is to assess the effects of tucatinib on the single-dose PK of metformin. Secondary objectives of the study are to (1) assess the safety and tolerability of metformin when coadministered with tucatinib and (2) assess the effects of tucatinib on renal function using iohexol as glomerular filtration rate (GFR) marker.
- Conditions
- Drug-drug Interaction
- Being tested
- Tucatinib, Metformin, Iohexol
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TucatinibDrug
150mg administered orally twice daily
MetforminDrug
850mg administered orally
IohexolDrug
1500 mg administered intravenously (IV)
| Study group | Role | What they receive |
|---|---|---|
| Tucatinib plus metformin | Experimental | Tucatinib administered twice daily on Days 2-8. Metformin administered as a single dose on Days 1 and 8. Iohexol administered via IV push on Days 1 and 8 Receives: Drug: Tucatinib; Drug: Metformin; Drug: Iohexol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum observed plasma concentration (Cmax) of metformin
Measured: Up to 9 days
Time to maximum observed plasma concentration (tmax) of metformin
Measured: Up to 9 days
Half-life (t1/2) of metformin
Measured: Up to 9 days
Area under the plasma concentration-time curve from time 0 to the last available measurement (AUC0-last) of metformin
Measured: Up to 9 days
Area under the plasma concentration time curve to time 0 extrapolated to infinity (AUC0-inf) of metformin
Measured: Up to 9 days
Apparent volume of distribution (V2/F) of metformin
Measured: Up to 9 days
Oral clearance (CL/F) of metformin
Measured: Up to 9 days
Secondary outcomes (2)
Incidence of adverse events (as assessed by AE assessments, clinical laboratory tests, physical examinations, vital signs measurements, and 12-lead electrocardiogram)
Measured: Up to 16 days
Glomerular Filtration Rate (GFR) as measured by iohexol plasma clearance
Measured: Up to 8 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2019
- Study start12 Feb 2019
- Primary completion8 Mar 2019
- Study completion15 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Drug-drug InteractionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seagen Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- JoAl Mayor, PharmD, BCOP, Study director, Seagen Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03826602
- Sponsor's protocol ID
- SGNTUC-020
- Status last verified
- Mar 2019
- First submitted
- 30 Jan 2019
- Last updated
- 27 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Zhang D, Taylor A, Zhao JJ, Endres CJ, Topletz-Erickson A. Population Pharmacokinetic Analysis of Tucatinib in Healthy Participants and Patients with Breast Cancer or Colorectal Cancer. Clin Pharmacokinet. 2024 Oct;63(10):1477-1487. doi: 10.1007/s40262-024-01412-0. Epub 2024 Oct 5.
PubMed 39368039
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Open-Label, Fixed-Sequence, Drug-Drug Interaction Study to Evaluate the Effects of Tucatinib of the Pharmacokinetics of Metformin in Healthy Male and Female Subjects
- ClinicalTrials.gov ID
- NCT03826602
- Acronym / sponsor ID
- SGNTUC-020
- Conditions
- Drug-drug Interaction
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Seagen Inc.Industry (pharma, biotech, devices)
- Study start
- 12 Feb 2019 (actual)
- Primary completion
- 8 Mar 2019 (actual)
- Study completion
- 15 Mar 2019 (actual)
- First posted
- 1 Feb 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is being done to look at how tucatinib might affect the way another drug (metformin) works. It will look at healthy volunteers and how tucatinib affects how the body absorbs metformin. This will help us find out whether tucatinib is safe to give together with metformin. The study will also look at how tucatinib affects how the kidneys work.
Detailed description
This is a single center, fixed-sequence, drug-drug interaction study to assess the effects of multiple oral doses of tucatinib on the pharmacokinetics of a single oral dose of metformin in healthy subjects. The primary objective of the study is to assess the effects of tucatinib on the single-dose PK of metformin. Secondary objectives of the study are to (1) assess the safety and tolerability of metformin when coadministered with tucatinib and (2) assess the effects of tucatinib on renal function using iohexol as glomerular filtration rate (GFR) marker.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Tucatinib plus metformin | Experimental | Drug: Tucatinib, Drug: Metformin, Drug: IohexolTucatinib administered twice daily on Days 2-8. Metformin administered as a single dose on Days 1 and 8. Iohexol administered via IV push on Days 1 and 8 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Healthy status, as defined by the absence of evidence of any clinically significant findings
- Males must agree to use a barrier method of birth control and not donate sperm during study plus 30 days after last dose of study drug
- Weight of ≥60kg
- Body mass index between 18.0 and 32.0 kg/m² (inclusive)
- Ability to abstain from alcohol-, caffeine-, and xanthine-containing food and beverages from 48 hours prior to admission through study discharge
Key exclusion criteria (14 listed)
- Females who are of childbearing potential or lactating
- Males with female partners who are pregnant, lactating, or planning to become pregnant within 30 days of the study
- Use of any investigational drug or device within 30 days of study start
- Use of tobacco products within 21 days prior to admission
- Routine or chronic use of more than 3 grams of acetaminophen daily
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tucatinib150mg administered orally twice daily | Drug | Tucatinib plus metformin |
| Metformin850mg administered orally | Drug | Tucatinib plus metformin |
| Iohexol1500 mg administered intravenously (IV) | Drug | Tucatinib plus metformin |
Primary outcome
Maximum observed plasma concentration (Cmax) of metformin
Time frame: Up to 9 days
Time to maximum observed plasma concentration (tmax) of metformin
Time frame: Up to 9 days
Half-life (t1/2) of metformin
Time frame: Up to 9 days
Area under the plasma concentration-time curve from time 0 to the last available measurement (AUC0-last) of metformin
Time frame: Up to 9 days
Area under the plasma concentration time curve to time 0 extrapolated to infinity (AUC0-inf) of metformin
Time frame: Up to 9 days
Apparent volume of distribution (V2/F) of metformin
Time frame: Up to 9 days
Oral clearance (CL/F) of metformin
Time frame: Up to 9 days
2 secondary outcomes
Incidence of adverse events (as assessed by AE assessments, clinical laboratory tests, physical examinations, vital signs measurements, and 12-lead electrocardiogram)
Time frame: Up to 16 days
Glomerular Filtration Rate (GFR) as measured by iohexol plasma clearance
Time frame: Up to 8 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2019.
- Derived from this study: PubMed 39368039Zhang D, Taylor A, Zhao JJ, Endres CJ, Topletz-Erickson A. Population Pharmacokinetic Analysis of Tucatinib in Healthy Participants and Patients with Breast Cancer or Colorectal Cancer. Clin Pharmacokinet. 2024 Oct;63(10):1477-1487. doi: 10.1007/s40262-024-01412-0. Epub 2024 Oct 5.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
JoAl Mayor, PharmD, BCOP study director
Seagen Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Tucatinib, Metformin and Iohexol in people with Drug-drug Interaction, run by Seagen Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum observed plasma concentration (Cmax) of metformin (time frame: Up to 9 days). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03826602, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2019.